Regulatory Compliance Services

Effectively resolving complex regulatory issues

Global industry leader in regulatory and compliance services

Flavine is proud to offer com­pre­hen­sive reg­u­la­to­ry ser­vices that are catered to your unique needs. As your pre­ferred reg­u­la­to­ry agent, we will work close­ly with you to effec­tive­ly resolve reg­u­la­to­ry issues and help sim­pli­fy the drug approval process with­in the Unit­ed States, Europe, Chi­na, India, Mid­dle East and North Africa. Our teams of reg­u­la­to­ry experts have decades worth of exper­tise work­ing with health author­i­ties such as the US FDA, EDQM, and CFDA. We under­stand how to suc­cess­ful­ly nav­i­gate the var­i­ous reg­u­la­to­ry land­scapes and assist you with your reg­u­la­to­ry and com­pli­ance requirements.

Full range of regulatory services

Our state of the art, GMP-com­pli­ant lab­o­ra­to­ry facil­i­ty in Vit­rolles, France offers com­pre­hen­sive ana­lyt­i­cal ser­vices, QC retest, and release test­ing of APIs and FDFs accord­ing to your spec­i­fi­ca­tions or com­pen­di­al. Com­ple­ment­ing our full-ser­vice QC test­ing, we also pro­vide robust method devel­op­ment, val­i­da­tion, and trans­fer of phar­ma­ceu­ti­cals and raw materials.

Regulatory Compliance


Master File and Dossier Preparation